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AMG-811 shows mixed results in patients with SLE in phase 1 study

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Amgen’s experimental AMG-811 may lower serum CXCL-10 and interferon-gamma-modulated mRNA levels in patients with systemic lupus erythematosus and lupus nephritis, according to recently presented data.

Researchers studied 28 patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN), with 21 patients randomly assigned to a treatment group with AMG-811, a human monoclonal antibody believed to inhibit interferon-gamma (IFN-g), and seven patients randomly assigned to a placebo. The study’s primary endpoints were safety, tolerability and the development of anti-drug antibodies.

Patients with SLE received 20 mg of AMG-811 and patients with LN received 60 mg for 12 weeks. Patients with LN had higher baseline serum CXCL-10 and IFN-g compared with patients without renal involvement. Although levels were reduced in both treatment groups compared with placebo, and some patients with SLE reached healthy levels, the reductions were “incomplete and transient,” according to the researchers.

Improvements in proteinuria were seen in some patients; however, the researchers noted that no consistent differences were observed at week 12 between the cohorts in renal outcomes or serum biomarkers related to SLE. Additionally, no anti-drug antibodies were detected in patients in the treatment groups.

The researchers described the overall safety profile as “acceptable” and wrote, “There were no discernible effects of AMG 811 on clinical or SLE-related serologic outcome measures over the treatment period although interpretation is challenging given the small sample size.”

According to Amgen’s website, AMG-811 is still being tested in phase 1 for patients with SLE. – by Shirley Pulawski

Reference:

Martin DA, et al. Paper #THU0389. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosure s : Martin is an employee of Amgen. Please see the full study for a list of all other authors’ relevant financial disclosures.